External Validation of VVI
ConditionWeaning Mechanical Ventilation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Thessaly
About this trial
Failure of liberation from mechanical ventilation increases days spent being mechanically ventilated, the length of stay and the morbidity of patients. Thus it is crucial that those patients who are ready to be liberated are accurately detected. In this study the investigators want to externally validate an index (the volume-velocity index, VVI) which in a preliminary study was found to predict with high accuracy the outcome of ventilator liberation.
In this study, in patients who are deemed ready to undergo weaning by their treating physician the investigators will measure the excursion of the diaphragm, the principal respiratory muscle, the inspiratory time and the tidal volume and the volume breathed by the patient at each respiration in three phases:
1. during pressure support ventilation with 5/5, 2. during pressure support ventilation with 8/0, 3. during t-tube or pressure support ventilation with 0/0. All of these phases are ventilatory modalities widely used during weaning from mechanical ventilation.
The investigators will evaluate whether VVI can predict accurately the weaning outcome.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Mechanically ventilated patients for more than 48h
First Spontaneous breathing trial
Deemed as ready to undergo weaning by the treating physician, according to published readiness criteria (DOI: 10.1183/09031936.00010206)
Disqualifiers
pregnant patients
preexisting diaphragmatic disease or injury
tracheostomy
Trial population
Critical Care patients undergoing weaning from mechanical ventilation
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: Patients undergoing weaning
Trial outcomes
Primary outcomes
1
Weaning outcome
Validate the predictive capability of VVI for weaning outcome
Time frame
From the start of the spontaneous breathing trial to failure or success at 48 hours after exubation.Secondary outcomes
1
VVI for SBT or extubation
Comparison of the capability of VVI to predict SBT or extubation failure
Time frame
From the start of the spontaneous breathing trial to failure or success at 48 hours after exubation.Other outcomes
1
VVI vs RSBI
Comparison of the predictive capability of VVI with RSBI for weaning outcome
Time frame
From the start of the spontaneous breathing trial to failure or success at 48 hours after exubation.2
Predictive capability of VVI between long or short ventilation time
Comparison of the redictive capability of VVI between patients ventilated for more than 7 days with patients ventilated for less than 7 days
Time frame
From the start of the spontaneous breathing trial to failure or success at 48 hours after exubation.3
VVI in various SBT modalities
Compare the ability of VVI to predict the weaning outcome in various SBT modalities, namely Pressure Support 8/0 and Pressure Support 5/5 versus t-tube or Pressure Support 0/0
Time frame
From the start of the spontaneous breathing trial to failure or success at 48 hours after exubation.4
Relationship of VVI with MIP and MRC
evaluate the relationship of VVI with indices of strength status such as the maximal inspiratory pressure, for the respiratory muscles, and the medical research council score, for the ICU acquired weakness.
Time frame
From the start of the spontaneous breathing trial to failure or success at 48 hours after exubation.Sponsors and contacts
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Source ClinicalTrials.gov